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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Endeavor Health | OTHER |
| University of Rochester | OTHER |
| Medical College of Wisconsin |
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-4 x 10^6 CD34+ stem cells/kg | Active Comparator | Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices. |
|
| 6-8 x10^6 CD34+ stem cells/kg | Experimental | Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leukapheresis | Procedure |
| ||
| Plerixafor |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | equals date of progression/death - date of Autologous Stem Cell Transplantation | at +/- 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the impact of CD34+ cell dose on lymphocyte subset recovery | (ALC15) post HDT-ASCT Accordingly, each subject will be classified as a responder (i.e., recovery) or non-responder. | day 15 |
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Inclusion Criteria:
Age ≥ 18 years old
Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy
KPS ≥ 70
Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.
Eligible for high-dose therapy and autologous stem-cell rescue
Total bilirubin < 2.0 mg/dL
o If Gilbert"s disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin must be < 2.0 mg/dL
Females of childbearing potential and males must agree to use an acceptable form of contraception per institutional practices.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Giralt, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States | ||
| Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| OTHER |
| University of Nebraska | OTHER |
| Sanofi | INDUSTRY |
| University Hospitals Seidman Cancer Center | OTHER |
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| Drug |
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for a maximum of 4 apheresis days, for the achievement of ≥ 7 x106 CD34+ cells/kg. |
|
| carmustine, etoposide, cytarabine, melphalan | Drug | Carmustine 300 mg/m2 day -6 Etoposide 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Cytarabine 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Melphalan 140 mg/m2 day -1 BEAM dosages may be adjusted per institutional dose adjustments based on body weight. |
|
|
| Autologous Stem Cell Transplantation | Procedure |
|
| Basking Ridge |
| New Jersey |
| United States |
| Memorial Sloan Kettering Monmouth (Consent and Follow up Only) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Consent and Follow Up Only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent and Follow-up Only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Northwell Health (Data collection only) | Manhasset | New York | 11030 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Columbia University | New York | New York | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Memorial Sloan Kettering Nassau (Consent and Follow up Only) | Uniondale | New York | 11553 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007937 | Leukapheresis |
| C088327 | plerixafor |
| D002330 | Carmustine |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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